NCT01358955已完成不适用
A Multicenter, Randomized Trial to Assess Efficacy of Home-based and Group Cognitive Intervention Programs in Amnestic Mild Cognitive Impairment
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 293
- 试验地点
- 25
- 主要终点
- Modified Alzheimer's Disease Assessment Scale-Cognitive subscale(ADAS-cog)
研究概览
简要总结
- There will be a significant difference in cognitive function between cognitive intervention group (group therapy) and a wait list control group.
- There will be a significant difference in cognitive function between a home-based cognitive intervention group and a wait list control group.
详细描述
The change of Modified ADAS-cog score from the baseline to post-intervention will be compared between the cognitive intervention group and wait list control group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •50 to 85 years of age
- •memory complaint corroborated by a participant and an informant
- •delayed recall score on the Seoul Verbal Learning Test (SVLT) below 1.0 standard deviations from the mean of the age and education-normative values among the Korean population
- •Global CDR score is 0.5, Memory CDR score is 0.5 or
- •above 1.5 standard deviations from the mean of normative data of the respective age- and education-matched population on the Korean Mini-Mental State Examination
- •normal functional activities
- •not diagnosed with dementia
- •Modified Hachinski Ischemic Score (HIS): 0-4
- •brain magnetic resonance imaging or CT showing no clinical evidence of other diseases (i.e., normal pressure hydrocephalus, brain tumor, cerebrovascular disease) capable of producing cognitive impairment.
- •Subjects are also required to have a reliable caregiver who meet the patient at least once a week and is sufficiently familiar with the patient to provide the investigator with accurate information.
- •He/She can read and write
- •written informed consent
排除标准
- •any patient who were involved in other clinical trials or treated with experimental drug within 4 weeks
- •any patients with any severe or unstable medical disease that may prevent the patient from completing all study requirements (i.e., unstable or severe asthma or cardiovascular disease, active gastric ulcer, severe hepatic or renal disease)
- •any patients with clinically significant laboratory abnormalities such as an abnormal thyroid function test, abnormal low level of vitamin B12 or folate, or positive venereal disease research laboratory test
- •any patients with any primary neurodegenerative disorder or psychiatric disorder other than AD (i.e., Parkinson's disease, schizophrenia, or major depressive disorder)
- •any patients with any history of drug or alcohol addiction during the past 10 years
- •any hearing or visual impairment that can disturb the efficient evaluation of the patient
结局指标
主要结局
Modified Alzheimer's Disease Assessment Scale-Cognitive subscale(ADAS-cog)
时间窗: postintervention, 12 weeks follow-up, and 24 weeks follow-up
次要结局
- CDR-SB(postintervention, 12 weeks follow-up, and 24 weeks follow-up)
- color-word stroop test(postintervention, 12 weeks follow-up, and 24 weeks follow-up)
- Digit symbol test(postintervention, 12 weeks follow-up, and 24 weeks follow-up)
- prospective memory test(postintervention, 12 weeks follow-up, and 24 weeks follow-up)
- Mini-Mental State Examination(postintervention, 12 weeks follow-up, and 24 weeks follow-up)
- story recall test(postintervention, 12 weeks follow-up, and 24 weeks follow-up)
- Digit span forward and backward(postintervention, 12 weeks follow-up, and 24 weeks follow-up)
- Word fluency test(postintervention, 12 weeks follow-up, and 24 weeks follow-up)
- K-AD8(postintervention, 12 weeks follow-up, and 24 weeks follow-up)
- PRMQ(postintervention, 12 weeks follow-up, and 24 weeks follow-up)
- MMQ-Strategy(postintervention, 12 weeks follow-up, and 24 weeks follow-up)
- QOL-AD(postintervention, 12 weeks follow-up, and 24 weeks follow-up)
- Geriatric Depression Scale-short form(postintervention, 12 weeks follow-up, and 24 weeks follow-up)
- Bayer ADL(postintervention, 12 weeks follow-up, and 24 weeks follow-up)
- CGA-NPI(postintervention, 12 weeks follow-up, and 24 weeks follow-up)
- Subjective cognitive assessment(postintervention, 12 weeks follow-up, and 24 weeks follow-up)
研究者
Chul Soo Kim
Professor
Inha University Hospital
研究点 (25)
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